Clinical trial · Interventional
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
A Randomized, Double-Blind Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Treatment-Naïve Unresectable or Metastatic Melanoma
NCT06054555CI-TRIAL-00100601active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ABP 206
- description
- Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
- interventionNames
- Drug: ABP 206
- type
- ACTIVE_COMPARATOR
- label
- Nivolumab
- description
- Subjects will receive Dose A of Nivolumab via IV infusion.
- interventionNames
- Drug: Nivolumab
Primary outcomes (5)
- measure
- Objective response by Week 49
- timeFrame
- Week 49
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Key Inclusion Criteria: * At least 18 years of age. * Histologically confirmed unresectable or metastatic melanoma. * Subject has no prior systemic treatment for advanced disease. * Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). * Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Key Exclusion Criteria: * Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma. * Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug. * Subject has active central nervous system (CNS) metastases not previously treated. * Ocular melanoma. * Subject has active or known immune-mediated disorders. * Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways. * Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product. Other protocol-defined inclusion/exclusion criteria apply.
References
Publications (0)
Data not yet available
No reference posted for this study.